National Health Registry Activities and 45 CFR part 46 (2011)

Important Note: OHRP posted the correspondence below in the belief that others may find it useful in understanding the applicability of the regulations.  Please note that OHRP issued this correspondence before the 2018 Requirements (i.e., the revised Common Rule) became effective, and therefore this document does not include citations or references to the 2018 Requirements.  However, OHRP continues to believe this correspondence could be useful to the regulated community.  An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at  45 CFR part 46.  For more information about the 2018 Requirements, please click here.

OHRP has posted its correspondence with the director of a national health registry in letters dated August 11, 2011 and December 29, 2011 responding to questions about the application of 45 CFR Part 46 to the activities related to the registry, in the belief that others may find the content to be useful.  The letters clarify the following points:

  • If research conducted by a registry is not part of or supported by HHS, or covered by an HHS federalwide assurance, then the regulatory requirements of 45 CFR 46 do not apply to that research activity even if it would be considered nonexempt human subjects research under those regulations.
  • The application of the regulations to an activity depend in part on whether the activity meets the regulatory definition of “research,” which depends on the specific facts of the activity, and not whether it is labeled “quality improvement” or something else.
  • A research registry could be designed so that the regulations would not apply to the creation and operations of the registry through various mechanisms, including the use of codes instead of identifiers in the original release of data to a registry, or the use of computer programming to merge identifiable data-sets without any person being able to view the data in identifiable form.
  • Institutions holding information originally obtained for clinical or administrative purposes whose agents simply release identifiable private information to a registry are not engaged in any research conducted by the registry, and do not have to meet any regulatory requirements of the 45 CFR 46 in this regard
  • Outside researchers who request the release of non-identifiable private information from the registry for secondary research analyses are not conducting “human subjects” research, and therefore the regulations do not apply to this activity, and there is no requirement for either IRB review or informed consent.
  • If healthcare providers enhance or extend their standard of care in follow-up interviews with their patients and those changes would have been implemented regardless of any secondary research purpose, then the data collected through those interviews would not be considered research; in contrast, if part of the reason for the change in interview data collected is for research, then the data collection would be considered part of a research activity.
  • Where appropriate, OHRP supports the use of single or central IRB review and approval of research conducted by clinical registries in circumstances where more than one institution is engaged in the research.

OHRP notes that the activities of such registries may also need to meet requirements under the Health Insurance Portability and Accountability Act (HIPAA), administered by the Office for Civil Rights (OCR). OHRP encourages institutions with questions about the HIPAA regulations to contact OCR directly, at (800) 368-1019.
OHRP is working to provide helpful information to institutions and the public regarding the applicability of the regulations to the various kinds of activities carried out by health registries and the institutions involved in some way in those activities. OHRP has asked the Secretary’s Advisory Committee on Human Research Protections (SACHRP) to provide recommendations related to this topic, and continues to develop information that can be used to protect human subjects in research and avoid unnecessary confusion and administrative burden.

The links below provide the full text of OHRP’s August 11, 2011 and December 29, 2011 response letters. The registry director agreed to the posting of OHRP's responses to his letters. Comments on this or other topics may be submitted to OHRP by email at ohrp@hhs.gov.  Please include the phrase “August 11, 2011 and December 29, 2011 letters regarding registries” in the subject filed. Alternatively, comments may be submitted to:

Office for Human Research Protections
1101 Wootton Parkway, Suite200
Rockville, MD 20852

• OHRP December 29, 2011 response 

• OHRP August 11, 2011 response 

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